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ElectroCore announced two clinical studies focused on expanding the use of non-invasive vagus nerve stimulation, or nVNS, for the acute and preventive treatment of migraine, and a recent publication of a real-world retrospective analysis which supports the use of nVNS as an effective therapeutic option for patients with cluster headache. A retrospective analysis, published in the Journal of Headache and Pain, examined data in chronic and episodic cluster headache patients who did not respond to or were intolerant of multiple preventive and/or acute treatments. Patients analyzed over an average of three to six months experienced a decrease in the frequency of cluster headache attacks, from 26.6 attacks per week to 9.5 attacks per week following initiation of nVNS, a mean difference of 17.1. Average cluster headache attack duration decreased from 51.9 minutes to 29.4 minutes following the initiation of nVNS, a mean difference of 22.5 and average cluster headache attack severity decreased from 7.8 to 6.0, a mean difference of 1.8. Adverse events were mild and transient, and consistent with previous studies. These results extend the findings of registration trials of nVNS in cluster headache patients including the PREVA pivotal study, a prospective, open-label, controlled, randomized clinical trial that demonstrated the safety and effectiveness of gammaCore as an adjunctive therapy for the preventive treatment of cluster headache. PREMIUM II, a multicenter, prospective, double-blind, randomized, sham-controlled study, will evaluate the efficacy and safety of nVNS for the preventive treatment of migraine. The study will enroll up to 500 patients in 35 sites in the United States, with an anticipated duration of 18 months. This study will be initiated in the EU shortly, to support the role of nVNS for the prevention or treatment of migraine compared with the patient's current therapy. This study will be initiated in the EU shortly, to support the role of nVNS for the prevention or treatment of migraine compared with the patient's current therapy.

ElectroCore announced that it received 510 clearance from the FDA for an expanded label for gammaCore therapy for adjunctive use for the preventive treatment of cluster headache in adult patients. This milestone marks the first and only product FDA cleared for the prevention of cluster headache. There are currently no FDA-approved pharmacologic treatments for the prevention of cluster headache. This clearance was supported by results from two studies, including from the PREVA pivotal study, a prospective, open-label, controlled, randomized clinical trial that demonstrated the safety and effectiveness of gammaCore as an adjunctive therapy for the preventive treatment of cluster headache. The second study reviewed by the FDA was a real world retrospective study examining the daily clinical use of gammaCore preventively and acutely for the treatment of cluster headache.